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OpenTrials
Completed

NCT Number: NCT02774616

BIO|MASTER.Ilivia Family / Plexa

Post-Market Clinical Follow-up of the new Ilivia ICD Family and the new Plexa right ventricular lead to fulfill requirements by the notified body and to support regulatory approval outside of the CE region

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Key information

Conditions

Heart Failure Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachyarrhythmia Tachycardia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Liverpool Hospital, Liverpool, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Standard indication for ICD or CRT-D therapy according to clinical practice
  • De novo implantation or upgrade/exchange (group A only) from existing ICD, CRT-D or pacemaker implant
  • Patient is able to understand the nature of the clinical investigation and provides written informed consent
  • Patient is able and willing to complete all routine study visits at the investigational site
  • Patient accepts Home Monitoring concept
  • Age ≥ 18 years

Exclusion criteria

  • Contraindication to ICD or CRT-D therapy, respectively
  • For CRT-D patients in group A only: physician not willing to activate MultiPole Pacing in the patient
  • Cardiac surgical procedure planned within 6 months after implantation (including also interventional procedures like ablation, valve replacement etc.). Procedures to occur during or prior to implantation are not exclusionary.
  • Expected to receive heart transplant or ventricular assist device within 6 months
  • Life expectancy less than 6 months
  • Participation in any other interventional clinical investigation
  • Pregnant or breastfeeding at time of enrollment

Treatment and study plan

Ilivia ICD Family

Device

pre-defined device programming, measurements and follow-up schedule

Plexa ICD lead

Device

predefined follow-up schedule

Primary outcomes

  1. Ilivia Family Related SADE-free Rate Through 3 Months

    Time frame: 3 months

    This endpoint measures the percentage of patients without serious adverse device effect (SADE) related to the ICD device

  2. Plexa Related SADE-free Rate Through 6 Months

    Time frame: 6 months

    This endpoint measures the percentage of patients without serious adverse device effect (SADE) related to the "Plexa" lead

Secondary outcomes

  1. Percentage of Patients With Successful Fast Ventricular Arrhythmia Conversion by ATP One-shot at 6-month Follow-up

    Time frame: 6 months

    Of all patients with spontaneous ventricular arrhythmia detected in the VF zone, and treated by "ATP-one-shot", the percentage of patients with at least one successful termination will be determined

  2. Rate of Appropriate Right Ventricular Sensing at 3-month Follow-up

    Time frame: 3 months

    The investigator is asked whether the sensing function of the Pleaxa lead in the right ventricle is appropriate

  3. Rate of Appropriate Right Ventricular Pacing at the 3 Months Follow-up

    Time frame: 3 months

    The investigator is asked whether the pacing function of the Pleaxa lead in the right ventricle is appropriate

Sponsors and collaborators

Lead sponsor

Biotronik SE & Co. KG

Industry

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
May 17, 2016
Registry last updated
May 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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